Pharmacokinetics and safety of a single intravenous dose of myo-inositol in preterm infants of 23-29 wk.

ABSTRACT:

Background

Myo-inositol given to preterm infants with respiratory distress has reduced death, increased survival without bronchopulmonary dysplasia, and reduced severe retinopathy of prematurity in two randomized trials. Pharmacokinetic (PK) studies in extremely preterm infants are needed before efficacy trials.

Methods

Infants born in 23-29 wk of gestation were randomized to a single intravenous (i.v.) dose of inositol at 60 or 120 mg/kg or placebo. Over 96 h, serum levels (sparse sampling population PK) and urine inositol excretion were determined. Population PK models were fit using a nonlinear mixed-effects approach. Safety outcomes were recorded.

Results

A single-compartment model that included factors for endogenous inositol production, allometric size based on

SUBMITTER: Phelps DL 

PROVIDER: S-EPMC3962781 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature